norethindrone acetate and ethinyl estradiol

Generic: norethindrone acetate and ethinyl estradiol

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone acetate and ethinyl estradiol
Generic Name norethindrone acetate and ethinyl estradiol
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ethinyl estradiol .0025 mg/1, norethindrone acetate .5 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-129
Product ID 75834-129_4ffa902e-2cf8-4160-ba1e-f27e48b8e502
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203435
Listing Expiration 2026-12-31
Marketing Start 2016-11-25

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834129
Hyphenated Format 75834-129

Supplemental Identifiers

RxCUI
1090992 1251323 1251334 1251336
UNII
9S44LIC7OJ 423D2T571U
NUI
N0000175825 N0000000100

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name norethindrone acetate and ethinyl estradiol (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol (source: ndc)
Application Number ANDA203435 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .0025 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (75834-129-29) / 28 TABLET in 1 BLISTER PACK (75834-129-84)
  • 90 TABLET in 1 BOTTLE (75834-129-90)
source: ndc

Packages (2)

75834-129-29 3 BLISTER PACK in 1 CARTON (75834-129-29) / 28 TABLET in 1 BLISTER PACK (75834-129-84) 75834-129-90 90 TABLET in 1 BOTTLE (75834-129-90)

Ingredients (2)

ethinyl estradiol (.0025 mg/1) norethindrone acetate (.5 mg/1)

Linked Drug Pages (1)

Norethindrone Acetate and Ethinyl Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4ffa902e-2cf8-4160-ba1e-f27e48b8e502", "openfda": {"nui": ["N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "423D2T571U"], "rxcui": ["1090992", "1251323", "1251334", "1251336"], "spl_set_id": ["2c2a37e1-adaf-4947-abb1-736bfa58bf98"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (75834-129-29)  / 28 TABLET in 1 BLISTER PACK (75834-129-84)", "package_ndc": "75834-129-29", "marketing_start_date": "20161125"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (75834-129-90)", "package_ndc": "75834-129-90", "marketing_start_date": "20161125"}], "brand_name": "Norethindrone Acetate and Ethinyl Estradiol", "product_id": "75834-129_4ffa902e-2cf8-4160-ba1e-f27e48b8e502", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "75834-129", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone Acetate and Ethinyl Estradiol", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".0025 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}], "application_number": "ANDA203435", "marketing_category": "ANDA", "marketing_start_date": "20161125", "listing_expiration_date": "20261231"}